Teva Pharmaceutical has announced that the FDA has granted tentative approval for the company's abbreviated new drug application (ANDA) to market its generic version of Novartis' hypertension treatment Lotrel (Amlodipine Besylate and Benazepril HCl) Capsules in 2.5 mg base/10 mg, 5 mg base/10 mg, 5 mg base/20 mg and 10 mg base/20 mg dosages.
Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A suit was brought against Teva in September 2004 involving its Paragraph IV certification to U.S. Patent No. 6,162,802. A trial date has not been set.
Final approval of
this product is anticipated upon expiry of U.S. Patent No. 4,879,303 in September